BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II)

    MDR report key: 14317607 · Received May 7, 2022

    Report

    Report Number
    1119779-2022-00665
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 13, 2022
    Report Date
    May 12, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, THE BD DS HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL #: 251239. LOT/BATCH #: 2024421. BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR CONTAMINATION WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES FROM BD INVENTORY WERE REVIEWED AND NO CONTAMINATION WAS FOUND. THIS COMPLAINT HAS BEEN CONFIRMED FOR CONTAMINATION BASED ON THE PHOTO PROVIDED. NO ISSUE WAS FOUND IN RETAINS AND NO TREND IDENTIFIED. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) PLATES WERE FOUND CONTAMINATED WITH BACTERIAL COLONIES WHILE UNPACKING THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT CONTAMINATION OF THE MEDIA. ACCORDING TO THE CUSTOMER¿S REPORT, BACTERIAL COLONIES WERE FOUND ON THE SURFACE OF THE MEDIA UPON UNPACKING."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) PLATES WERE FOUND CONTAMINATED WITH BACTERIAL COLONIES WHILE UNPACKING THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT CONTAMINATION OF THE MEDIA. ACCORDING TO THE CUSTOMER¿S REPORT, BACTERIAL COLONIES WERE FOUND ON THE SURFACE OF THE MEDIA UPON UNPACKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758342 BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 2024421

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown